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| Sponsored by: |
Schering-Plough |
|---|---|
| Information provided by: | Schering-Plough |
| ClinicalTrials.gov Identifier: | NCT00406783 |
Purpose
This study will investigate the effectiveness of desloratadine in treating subjects with allergic rhinitis (AR) who meet the criteria for intermittent allergic rhinitis.
| Condition | Intervention | Phase |
|---|---|---|
|
Rhinitis, Allergic, Seasonal Rhinitis, Allergic, Perennial |
Drug: 5-mg Desloratadine Drug: Placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multicenter/Multinational, Efficacy and Safety Study of Desloratadine 5 mg in the Treatment of Subjects With Allergic Rhinitis Who Meet the Criteria for Intermittent Allergic Rhinitis (IAR) |
| Enrollment: | 547 |
| Study Start Date: | August 2006 |
| Study Completion Date: | November 2007 |
| Arms | Assigned Interventions |
|---|---|
| 5-mg Desloratadine tablet: Experimental |
Drug: 5-mg Desloratadine
5-mg Desloratadine tablet, once daily for 15 days
|
| Placebo tablet: Placebo Comparator |
Drug: Placebo
Placebo tablet, once daily for 15 days
|
Eligibility| Ages Eligible for Study: | 12 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
The subject must meet ALL of the criteria listed below for entry:
Exclusion Criteria:
The subject will be excluded from entry if ANY of the criteria listed below are met:
Contacts and Locations
More Information
| Responsible Party: | Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group ) |
| Study ID Numbers: | P04683 |
| Study First Received: | November 29, 2006 |
| Results First Received: | November 21, 2008 |
| Last Updated: | March 5, 2009 |
| ClinicalTrials.gov Identifier: | NCT00406783 History of Changes |
| Health Authority: | Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment |
|
Allergic Rhinitis Intermittent Allergic Rhinitis |
|
Neurotransmitter Agents Otorhinolaryngologic Diseases Cholinergic Antagonists Rhinitis Cholinergic Agents Desloratadine Histamine Hypersensitivity Histamine Antagonists |
Rhinitis, Allergic, Perennial Respiratory Tract Diseases Respiratory Tract Infections Rhinitis, Allergic, Seasonal Hypersensitivity, Immediate Histamine phosphate Histamine H1 Antagonists Respiratory Hypersensitivity |
|
Neurotransmitter Agents Otorhinolaryngologic Diseases Molecular Mechanisms of Pharmacological Action Immune System Diseases Cholinergic Antagonists Physiological Effects of Drugs Histamine Agents Rhinitis Cholinergic Agents Desloratadine Pharmacologic Actions |
Nose Diseases Hypersensitivity Histamine Antagonists Rhinitis, Allergic, Perennial Respiratory Tract Diseases Respiratory Tract Infections Rhinitis, Allergic, Seasonal Hypersensitivity, Immediate Histamine H1 Antagonists Histamine H1 Antagonists, Non-Sedating Respiratory Hypersensitivity |